Location: Bengaluru

Experience: 5- 8 Yrs

Job code: AIOC-S01639556

Skills: Clinical Data Services - Medical Monitoring

Education: Any


**What Would You Do?**

You will be aligned with the Life Sciences R&D vertical. The services span the entire life sciences enterprise, including research laboratories, clinical trial support, regulatory services, pharmacovigilance, and patient services solutions.


Clinical Data Services involves managing and processing data collected during clinical trials. This includes data collection, validation, storage, and analysis to ensure accuracy and reliability. The goal is to support clinical research by providing high-quality data used to evaluate the safety and efficacy of medical treatments.


The role provides medical expertise for trial oversight and safety concerns, including the creation, review, and validation of protocol requirement specifications in accordance with applicable Standard Operating Procedures (SOPs).


**What Are We Looking For?**

* Strong analytical skills

* Problem-solving skills

* Strong written and verbal communication skills


**Roles and Responsibilities:**

1. Analyze and solve moderately complex problems, including designing solutions by leveraging and adapting existing methods and procedures.

2. Understand and align work with the strategic direction and team goals defined by senior management.

3. Receive guidance on methods and procedures for new assignments while working independently on routine tasks.

4. Interact primarily with the direct supervisor, with periodic interaction with clients and senior management.

5. Make decisions that impact individual deliverables and may influence team outcomes.

6. Function as an individual contributor and/or manage small teams or work efforts.

7. Work in rotational shifts as required.

8. Act as an interface between study teams, offshore teams, and onshore/client stakeholders.

9. Collaborate with Senior Statistical Programmers, study leads, and programmers to ensure smooth study execution.

10. Perform Quality Control (QC) checks for standard and non-standard safety and efficacy deliverables.

11. Review approved protocols, study setup documents, submission documents, and output specifications.

12. Develop SAS programs and execute standard macros to generate SDTM-like datasets, SDTM datasets, tables, listings, figures, and trial-specific outputs.

13. Perform developer testing and validate datasets and outputs in compliance with defined standards.

14. Leverage programming and data standards to maximize efficiency and consistency across studies.

15. Maintain project, validation, and programming documentation in accordance with SOP requirements.

16. Adhere to all applicable client and organizational SOPs and quality guidelines.

17. Mentor and guide new hires, support onboarding, and address technical or process-related queries.

18. Conduct and assess Service Readiness Assessments for new resources.

19. Support resource management activities for ongoing and upcoming studies.

20. Assist Statistical Programming Managers and Service Delivery Leads with operational reporting and daily support.

21. Complete assigned training within defined timelines and continuously enhance technical skills.

22. Support non-clinical, organizational, and business excellence initiatives and task forces.